Ra Qm Skills
技能 活跃12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO, risk management (ISO 14971), CAPA, document control, auditing. Python tools (stdlib-only).
To provide AI agents with deep domain expertise in regulatory affairs and quality management, enabling them to assist with compliance tasks, audits, and documentation for regulated industries.
功能
- 12 specialized regulatory & QM skills
- Supports ISO 13485, MDR 2017/745, FDA, ISO 27001, GDPR
- Python tools using only the standard library
- Covers risk management, CAPA, document control, and auditing
使用场景
- Assisting with FDA 510(k) or PMA submissions
- Implementing and managing ISO 13485 QMS
- Conducting ISO 27001 security audits
- Ensuring GDPR/DSGVO compliance
非目标
- Replacing legal counsel or expert human auditors
- Providing definitive compliance certification
- Handling general coding or DevOps tasks
Compliance
- info:GDPRWhile the extension covers GDPR/DSGVO, it does not specify how personal data is handled or sanitized if submitted to the LLM.
Scope
- warning:Tool surface sizeThe repository contains 12 distinct skills, each likely comprising multiple tools, potentially exceeding the ideal range.
安装
请先添加 Marketplace
/plugin marketplace add alirezarezvani/claude-skills/plugin install ra-qm-team@claude-code-skills质量评分
类似扩展
Qms Audit Expert
100ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management.
Capa Officer
98CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.
Prepare Inspection Readiness
100Prepare an organisation for regulatory inspection by assessing readiness against agency-specific focus areas (FDA, EMA, MHRA). Covers warning letter and 483 theme analysis, mock inspection protocols, document bundle preparation, inspection logistics, and response template creation. Use when a regulatory inspection has been announced or is anticipated, when a periodic self-assessment is due, when new systems have been implemented since the last inspection, or after a significant audit finding that may attract regulatory attention.
Gdpr Dsgvo Expert
100GDPR and German DSGVO compliance automation. Scans codebases for privacy risks, generates DPIA documentation, tracks data subject rights requests. Use for GDPR compliance assessments, privacy audits, data protection planning, DPIA generation, and data subject rights management.
Design Training Program
99Design a GxP training programme covering training needs analysis by role, curriculum design (regulatory awareness, system-specific, data integrity), competency assessment criteria, training record retention, and retraining triggers for SOP revisions and incidents. Use when a new validated system requires user training before go-live, an audit finding cites inadequate training, organisational changes introduce new roles, a periodic programme review is due, or inspection preparation requires demonstrating training adequacy.
Alterlab Fda
99Query openFDA API for drugs, devices, adverse events, recalls, regulatory submissions (510k, PMA), substance identification (UNII), for FDA regulatory data analysis and safety research. Part of the AlterLab Academic Skills suite.